Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004154
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

December 10, 1999
January 27, 2003
June 17, 2016
June 2000
March 2005   (Final data collection date for primary outcome measure)
Recurrence rate of transitional cell carcinoma (TCC) [ Time Frame: 1 year ]
Recurrence rates is defined as proportion of participants who recur within one year of surgery.
Not Provided
Complete list of historical versions of study NCT00004154 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor.

PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.


  • Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
  • Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.

Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.

Patients are followed every 3 months for 15 months.

PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.

Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Bladder Cancer
  • Drug: Fenretinide
    200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
    Other Name: 4-HPR
  • Other: Placebo
    Two placebo capsules for 25 days of 28 day cycle.
  • Experimental: Fenretinide
    Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
    Intervention: Drug: Fenretinide
  • Placebo Comparator: Placebo
    Placebo orally every day for 12 months, taken 25 out of every 28 days.
    Intervention: Other: Placebo
Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
March 2005
March 2005   (Final data collection date for primary outcome measure)


  • Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria:

    • Newly diagnosed and no more than 4 weeks since resection
    • Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months OR
  • Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with Bacillus Calmette-Guerin (BCG).

    • Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG.
  • Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned
  • No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection
  • No metastatic disease



  • 18 and over

Performance status:

  • Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2

Life expectancy:

  • At least 2 years


  • white blood count (WBC) greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 11.0 g/dL


  • serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than 1.5 times upper limit of normal (ULN)


  • Creatinine less than 2.0 mg/dL


  • Triglyceride level less than 2.5 times ULN
  • No other concurrent malignancy except nonmelanomatous skin cancer
  • No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after the study participation


Biologic therapy:

  • See Disease Characteristics
  • No concurrent systemic biologic therapy


  • See Disease Characteristics
  • No prior systemic cytotoxic chemotherapy for bladder cancer
  • At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer
  • No concurrent systemic chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to the bladder
  • No concurrent radiotherapy


  • See Disease Characteristics


  • At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day)
  • At least 3 months since prior retinoid therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
ID95-236 ( Other Identifier: UT MD Anderson Cancer Center )
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Anita L. Sabichi, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP